3-Dimensional Accelerometer Sub-Study
This is a prospective, unblinded sub-study to the E-30 to gather physiological data.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||3-Dimensional Accelerometer Sub-Study for Patients Participating in the E-30 Study: Heart Rate Changes in Subjects With Epilepsy During an Epilepsy Monitoring Unit Admission|
- Gather physiological data [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]The purpose of this sub-study is to gather physiological data in consenting subjects who were previously enrolled in the "parent" E-30 study (NCT01202669).
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
|Experimental: Physiologic Data Collection||
Device: Accelerometer Device
A sensor platform that enables physiological monitoring in routine, home or office environments.
This sub-study to the E-30 is designed to collect vital signs, accelerometer and ECG data on subjects, and will consist of two phases. Phase 1 is designed to collect data in an Epilepsy Monitoring Unit (EMU) and Phase 2 is designed to collect data in an everyday (ambulatory) setting.
|United States, Florida|
|Gainesville, Florida, United States, 32610|
|United States, Illinois|
|Chicago, Illinois, United States, 60637|
|Study Director:||Bryan Olin||Cyberonics, Inc.|